0910-AI07 202504 Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Protection of Human Subjects and Institutional Review Boards

This rule will harmonize, to the extent practicable and consistent with other statutory provisions, certain provisions of FDA’s regulations on human subject protection and institutional review boards with the revised "Federal Policy for the Protection of Human Subjects” (the revised Common Rule (45 CFR part 46, subpart A)). The rule also finalizes minor amendments to related regulatory provisions.

]]> Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes No Deregulatory 21 CFR 50 21 CFR 56 21 CFR 812 21 U.S.C. 343 21 U.S.C. 346 21 U.S.C. 348 21 U.S.C. 350a and 350b 21 U.S.C. 353 21 U.S.C. 355 21 U.S.C. 360 21 U.S.C. 360c to 360e 21 U.S.C. 360j 21 U.S.C. 360hh to 360pp 21 U.S.C. 360rr to 360ss 21 U.S.C. 371 21 U.S.C. 379e 42 U.S.C. 262 Statutory NPRM 12/13/2019 Section 3023 of the 21st Century Cures Act No NPRM 09/28/2022 87 FR 58733 NPRM Comment Period End 11/28/2022 NPRM Comment Period Extended 11/14/2022 87 FR 68118 NPRM Comment Period Extended End 12/28/2022 Final Rule 09/00/2025 Undetermined None No No No No Shari Targum Deputy Director 0910 Food and Drug Administration FDA 301 796-1151 shari.targum@fda.hhs.gov Office of Clinical Policy, 10903 New Hampshire Avenue, WO Bldg. 32, Rm. 5170, Silver Spring MD 20993